Use of anesthetic for execution might cut supply

ST. LOUIS -- The planned use of a common anesthetic in a Missouri execution is raising concerns that the anti-death penalty European Union could limit export of the drug, endangering the supply of a vital medication used every day in thousands of American hospitals and clinics.

The execution scheduled for Oct. 23 would be the first to use propofol, which is by far the nation's most popular anesthetic.

About 50 million vials are administered annually in some 15,000 locations. That's about four-fifths of all anesthetic procedures, according to the American Society of Anesthesiologists. Propofol is popular because it works quickly and patients wake up faster with fewer side effects such as postoperative nausea.

Roughly 85 percent of the U.S. supply of propofol is made in Europe, where capital punishment is outlawed, by the German company Fresenius Kabi. Export is controlled by the European Union, which prohibits trade in goods that could be used for executions. The EU is reviewing whether to subject propofol to that rule.

'Real concern'

If it is added to the regulation, propofol would be subject to export controls, not a complete ban, EU spokeswoman Maja Kocijancic said.

Still, any change in export practices could have a drastic effect on propofol's availability in the U.S., said Matt Kuhn, a spokesman for Fresenius Kabi USA.

"It's a real concern," Kuhn said Friday. "And it could have enormous public health implications."

Fresenius Kabi has launched a website specifically to address the ramifications of using propofol in a U.S. execution, http://propofol-info.com.

The Food and Drug Administration is worried about any move that could affect access to propofol. FDA spokeswoman Erica Jefferson said the agency is weighing how to reach out to European officials to ensure the drug remains readily available.

"We do consider this a critical need," Jefferson said. "Without the drug, we're concerned that surgeries would be delayed and patients would be at risk."

Until recently, Missouri and other states with the death penalty used virtually the same three-drug protocol. That changed in recent years as drugmakers stopped selling the traditional execution drugs to prison officials because they didn't want them used for lethal injections.

Last year, the Missouri Department of Corrections turned to propofol, which made headlines in 2009 when pop star Michael Jackson died after overdosing on the drug. So far, Missouri is the only state to adopt propofol for executions, though it has not yet put anyone to death with the drug.

Missouri executions

At one point, the shortage of execution drugs was so concerning in the state that Attorney General Chris Koster hinted that use of the gas chamber was a possible alternative. Missouri used gas for executions in the early 1900s but no longer has a working chamber.

The October execution involves Allen Nicklasson, who was convicted of killing a man who stopped to help after Nicklasson's car broke down on a highway in 1994.

About a month later, Joseph Franklin is scheduled to die for a fatal 1997 shooting at a St. Louis area synagogue. Franklin was also convicted of racially motivated killings in Utah and Wisconsin, and bombing a synagogue in Tennessee.

Missouri corrections spokesman David Owen has said the state has enough propofol for the two planned executions and one more, with the last batch expiring in February 2015. He did not return messages seeking comment on Friday.

A European Union regulation limits export of goods used in "capital punishment, torture or other cruel, inhuman or degrading treatment or punishment."

Kocijancic said the review to determine whether propofol should be subject to that rule was in its "final stages." She declined to speculate when a decision would be made.

Supplies to U.S. hospitals and clinics would require authorization "but would still be possible," she wrote in a written response to questions.

If propofol is added to the regulation, Fresenius Kabi would have to apply for a separate export license for every shipment, "a process that could take three to six months in every instance," the company's website said. The result, it said, would be "a significant market shortage of this medically necessary drug across the U.S."

The U.S. has dealt with propofol shortages before, most recently in 2012 because of manufacturing problems. The American Society of Anesthesiologists said shortages resulted in less optimal outcomes, longer recovery times, medication errors and even deaths.

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Online:

http://propofol-info.com